MONOVISC Revenue Increases 24% Year-over-Year
Total Revenue Grows 5% Year-over-Year
Commercially Launches ORTHOVISC-T in Europe
BEDFORD, Mass., May 03, 2017 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global, integrated orthopedic medicines company
specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the first quarter ended
March 31, 2017, along with business progress in the periods.
“We made important progress executing our long-term growth strategy in the first quarter of 2017,” said Charles H. Sherwood,
Ph.D., President and Chief Executive Officer. “We finalized the clinical study design for an additional Phase III clinical trial of
CINGAL, and we commenced planning and site initiation activities for the trial in the quarter. MONOVISC continued its strong
momentum with revenue growth of 24% year-over-year for the quarter, and we achieved a significant milestone in our global expansion
with the launch of ORTHOVISC-T in Europe.”
First Quarter Financial Results
- Total revenue for the first quarter of 2017 increased 5% to $23.4 million, compared to $22.3 million for the first quarter of
2016.
- Worldwide Orthobiologics revenue grew 3% year-over-year in the first quarter of 2017. MONOVISC revenue increased 24%
year-over-year in the first quarter of 2017, and it was the main revenue growth driver in the period.
- International Orthobiologics revenue increased 12% for the first quarter of 2017, due primarily to the global expansion of
MONOVISC, as well as the growth of CINGAL in Europe and Canada. Domestically, ORTHOVISC and MONOVISC continue to maintain a
combined market leading position.
- Total operating expenses for the first quarter of 2017 were $15.4 million, compared to $11.6 million for the first quarter of
2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance
the Company’s product pipeline, expanded operational efforts, and increased professional service fees.
- Net income for the first quarter of 2017 was $5.5 million, or $0.37 per diluted share, compared to $6.9 million, or $0.45 per
diluted share, for the first quarter of 2016. The decline in net income was due primarily to the planned increase in operating
expenses previously discussed.
Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:
- Finalizing the clinical study design for an additional Phase III clinical trial of CINGAL, and commencing site initiation
activities for the trial. The trial is a randomized, double-blind, active comparator controlled, multi-center study of CINGAL to
demonstrate that CINGAL provides symptomatic relief of osteoarthritis of the knee in patients who have not responded to
conservative treatment.
- Launching ORTHOVISC-T in Europe to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
- Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for
cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
- Progressing the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate
headquarters.
- Completing the build-out of the Company’s new European headquarters and training center in Padova, Italy.
Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow,
Thursday, May 4th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or
1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika
website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the
event.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ:ANIK) is a global, integrated orthopedic medicines company
based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic
diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management
to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and
commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA,
and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For
more information about Anika, please visit www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in this press release, which are not statements of historical fact, are forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to
significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated
future results, performance, or achievements described in the forward-looking statements as a result of a number of factors
including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products
on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and
international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or
other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or
without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s
research and product development efforts and their relative success, including whether we have any meaningful sales of any new
products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing
operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well
as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to
products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in
the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x)
the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic
reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company
on the date of this press release, and the Company assumes no obligation to update the information contained in this press
release.
|
|
|
|
|
Anika Therapeutics, Inc. and
Subsidiaries |
Condensed Consolidated Statements of
Operations |
(in thousands, except per share
data) |
(unaudited) |
|
|
|
|
|
|
|
For the Three Months Ended March
31, |
|
|
|
2017 |
|
|
|
2016 |
|
Product revenue |
|
$ |
23,381 |
|
|
$ |
22,278 |
|
Licensing, milestone and contract revenue |
|
|
5 |
|
|
|
5 |
|
Total revenue |
|
|
23,386 |
|
|
|
22,283 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of product revenue |
|
|
6,083 |
|
|
|
5,425 |
|
Research & development |
|
|
4,230 |
|
|
|
2,159 |
|
Selling, general & administrative |
|
|
5,067 |
|
|
|
3,990 |
|
Total operating expenses |
|
|
15,380 |
|
|
|
11,574 |
|
Income from operations |
|
|
8,006 |
|
|
|
10,709 |
|
Interest income, net |
|
|
58 |
|
|
|
72 |
|
Income before income taxes |
|
|
8,064 |
|
|
|
10,781 |
|
Provision for income taxes |
|
|
2,571 |
|
|
|
3,886 |
|
Net income |
|
$ |
5,493 |
|
|
$ |
6,895 |
|
|
|
|
|
|
Basic net income per share: |
|
|
|
|
Net income |
|
$ |
0.38 |
|
|
$ |
0.46 |
|
Basic weighted average common shares outstanding |
|
|
14,576 |
|
|
|
14,875 |
|
Diluted net income per share: |
|
|
|
|
Net income |
|
$ |
0.37 |
|
|
$ |
0.45 |
|
Diluted weighted average common shares outstanding |
|
|
15,043 |
|
|
|
15,307 |
|
|
|
|
|
|
|
|
|
|
|
Anika Therapeutics, Inc. and
Subsidiaries |
Condensed Consolidated Balance
Sheets |
(in thousands, except per share
data) |
(unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December
31, |
ASSETS |
|
|
2017 |
|
|
|
2016 |
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
119,368 |
|
|
$ |
104,261 |
|
Investments |
|
|
19,250 |
|
|
|
20,500 |
|
Accounts receivable, net of reserves of $196 and $194 at March 31,
2017 and December 31, 2016, respectively |
|
|
21,079 |
|
|
|
27,598 |
|
Inventories |
|
|
16,180 |
|
|
|
15,983 |
|
Prepaid expenses and other current assets |
|
|
1,173 |
|
|
|
2,098 |
|
Total current assets |
|
|
177,050 |
|
|
|
170,440 |
|
Property and equipment, net |
|
|
51,593 |
|
|
|
52,296 |
|
Long-term deposits and other |
|
|
1,234 |
|
|
|
69 |
|
Intangible assets, net |
|
|
10,162 |
|
|
|
10,227 |
|
Goodwill |
|
|
7,328 |
|
|
|
7,214 |
|
Total assets |
|
$ |
247,367 |
|
|
$ |
240,246 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
6,050 |
|
|
$ |
2,303 |
|
Accrued expenses and other current liabilities |
|
|
4,167 |
|
|
|
6,496 |
|
Total current liabilities |
|
|
10,217 |
|
|
|
8,799 |
|
Other long-term liabilities |
|
|
400 |
|
|
|
2,126 |
|
Deferred tax liability |
|
|
6,722 |
|
|
|
6,548 |
|
Commitments and contingencies |
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Preferred stock, $.01 par value; 1,250 shares authorized, no shares
issued and outstanding at December 31, 2016 and December 31,
2015, respectively |
|
|
- |
|
|
|
- |
|
Common stock, $.01 par value; 60,000 and 30,000 shares
authorized, 14,655 and 14,627 shares issued and outstanding at
March 31, 2017 and December 31, 2016, respectively |
|
|
146 |
|
|
|
146 |
|
Additional paid-in-capital |
|
|
63,719 |
|
|
|
61,735 |
|
Accumulated other comprehensive loss |
|
|
(7,025 |
) |
|
|
(7,317 |
) |
Retained earnings |
|
|
173,188 |
|
|
|
168,209 |
|
Total stockholders’ equity |
|
|
230,028 |
|
|
|
222,773 |
|
Total liabilities and stockholders’ equity |
|
$ |
247,367 |
|
|
$ |
240,246 |
|
|
|
|
|
|
Anika Therapeutics, Inc. and
Subsidiaries |
Supplemental Financial
Data |
|
|
|
|
|
|
|
|
Revenue by Product Line and Product Gross
Margin |
(in thousands, except
percentages) |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months
Ended March 31, |
Product Line: |
|
|
2017 |
|
% |
|
|
2016 |
|
% |
Orthobiologics |
|
$ |
20,227 |
|
87 |
% |
|
$ |
19,587 |
|
88 |
% |
Surgical |
|
|
1,296 |
|
5 |
% |
|
|
1,318 |
|
6 |
% |
Dermal |
|
|
425 |
|
2 |
% |
|
|
381 |
|
2 |
% |
Other |
|
|
1,433 |
|
6 |
% |
|
|
992 |
|
4 |
% |
Product Revenue |
|
$ |
23,381 |
|
100 |
% |
|
$ |
22,278 |
|
100 |
% |
|
|
|
|
|
|
|
Product Gross Profit |
|
$ |
17,298 |
|
|
|
$ |
16,853 |
|
|
Product Gross Margin |
|
|
74% |
|
|
|
|
76% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Revenue by Geographic
Region |
(in thousands, except
percentages) |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months
Ended March 31, |
|
|
|
2017 |
|
% |
|
|
2016 |
|
% |
Geographic Region: |
|
|
|
|
|
|
United States |
|
$ |
18,930 |
|
81 |
% |
|
$ |
18,011 |
|
81 |
% |
Europe |
|
|
2,829 |
|
12 |
% |
|
|
2,565 |
|
11 |
% |
Other |
|
|
1,622 |
|
7 |
% |
|
|
1,702 |
|
8 |
% |
Product Revenue |
|
$ |
23,381 |
|
100 |
% |
|
$ |
22,278 |
|
100 |
% |
|
|
|
|
|
|
|
CONTACT:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
Sylvia Cheung, CFO
Tel: 781-457-9000